CN102470028B

CN102470028B - Tubular filter

Info

Publication number: CN102470028B
Application number: CN201080032845.9A
Authority: CN
Inventors: A·J·钱杜斯克; M·A·兰德尔
Original assignee: CR Bard Inc
Current assignee: CR Bard Inc
Priority date: 2009-07-29
Filing date: 2010-07-29
Publication date: 2015-04-15
Anticipated expiration: 2030-07-29
Also published as: US20150238302A1; US20210068939A1; CA2769208A1; CN102470028A; JP2013500787A; JP5685253B2; EP3505136A1; EP2459119B1; BR112012001978B8; US10813738B2; EP2459119A1; BR112012001978B1; BR112012001978A2; US9017367B2; US9486304B2; US20190336263A1; MX2012001288A; ES2717424T3; US9895214B2; US11730583B2

Abstract

A filter (300) to be placed in a flow of blood through a vessel. The filter includes a hub (310) disposed along a longitudinal axis and a plurality of anchor members (330) extending from the hub. Each anchor member includes either a cranial extension (340) or a caudal extension (350) at a distal end thereof. At least one anchor member distal end is spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator (320) members extending from the hub, the locator members alternatingly interposed between the anchor members.

Description

Tubular filter

Priority

This application claims the U.S. Provisional Patent Application No.61/229 enjoying and submitting on July 29th, 2009, the priority of 580, and the application is the U.S. Patent application No.11/429 submitted on May 9th, 2006, the part continuation application of 975, U.S. Patent application No.11/429,975 require to enjoy the U.S. Provisional Patent Application No.60/680 submitted on May 12nd, 2005, the priority of 601.The full content of above-mentioned each application is thus by reference to being contained in this.

Background technology

In recent years, designed multiple medical treatment device, described medical treatment device is suitable for being compressed into less size so that introduce in vascular access, and expansible one-tenth contacts the wall of vascular access subsequently.These medical treatment devices especially comprise thrombus filter, and described thrombus filter is expanded and is held in place by engaging with such as venacaval vein inwall.These vena cava filters are designed to for good and all be held in place.These filters comprise structure in place for filter anchoring in caval vein, such as, have the elongated bifurcated anchorage element of hooked end, described hooked end penetration rate of blood tube wall and prevent the arbitrary longitudinal direction migration along blood vessel definitely.Hook portion on the filter of the type is rigidity and does not bend, and after the filter of the type has been implanted two in thoughtful six weeks, bifurcated anchorage element grows endothelial layer, and endothelial layer is in place by hook locks definitely.Any trial of present removal filter can cause injury caval vein or destroy venacaval risk.

Under the multiple patient's condition and medical procedure make patient be in the risk of the pulmonary infarction of short-term, described pulmonary infarction can be alleviated by filter implants.In these cases, patient is often unwilling to receive permanent implant, because the risk of pulmonary infarction can disappear after the time of a few weeks or months.But, most of existing filter be held in place exceed a few week after be not easy to remove or dangerous removal, and therefore, also can not cause the long-term provisional filter injuring blood vessel wall when removing.

In the trial that a kind of removable filter is provided, form two filter webs along the central shaft with tepee structure, and each filter webs is formed by isolated pole (struts), described pole is from the center hub for filter webs to external radiation.Center hub is kept separately by compression unit, and the localizer component of two filter webs is overlapped into and makes two filter webs facing with each other.The removal device that such filter needs use two to insert in each end of filter, to pull open filter webs and to make compression unit break.The end segment of localizer component is formed and becomes substantially parallel relation to be in blood vessel wall, and tip slopes inwardly to avoid blood vessel wall to penetrate.If the device of the type was recalled grow endothelial layer on localizer component before, then minimize the destruction of blood vessel wall.But after endotheliocyte layer growth, the inside lengthwise movement of the combination of filter sections is opened along with filter sections and can tears this endothelial layer.

Each in following patent and disclosed patent application relates to IVC or blood filter, and its full content is thus by reference to being contained in this: USPN 5,059,205; USPN6,007,558; USPN 6,273,901; USPN 6,287,332; USPN 6,589,266; USPN7,338,512; USPN 7,544,202; USPN 7,625,390; The open NO.2007/0167974 of the U.S.; The open NO.2007/0198050 of the U.S.; The open NO.2008/0039891 of the U.S.; WO 1999/025252; WO 2002/0004060; WO 2004/098459; WO 2004/098460; WO 2005/072645; WO 2005/102437; WO2005/102439; WO 2006/036457; WO 2006/124405; WO 2007/100619; And WO 2007/106378.

Summary of the invention

Various embodiments provides a kind of removable blood filter, and described removable blood filter is allowed for the embolus by using in multiple localizer and multiple anchoring piece filtration blood vessel.In an aspect, the filter be placed in the transvascular blood stream of stream comprises hub, at least one anchoring piece and at least one localizer.Hub can axis arranged along the longitudinal.At least one anchoring piece is given prominence to from hub and is comprised hook portion, and described hook portion is penetration rate of blood tube wall when filter is placed in blood vessel.Hook portion can along the longitudinal axis from spaced apart and first radial distance spaced apart with longitudinal axis of hub.At least one localizer has the tip engaged with blood vessel wall or the part of localizer.Tip can along the longitudinal axis from spaced apart and second radial distance spaced apart with longitudinal axis of hub.Second radial distance can be less than the first radial distance.At least one localizer has at least four parts, and each in described at least four parts can be arranged on axis different accordingly.

In one aspect of the method, various embodiments also provides a kind of filter be placed in the transvascular blood stream of stream.Filter comprises hub, at least one anchoring piece and at least one localizer.Hub can axis arranged along the longitudinal.At least one anchoring piece is given prominence to from hub, and comprises hook portion, and described hook portion is penetration rate of blood tube wall when filter is placed in blood vessel.Hook portion can along the longitudinal axis from spaced apart and first radial distance spaced apart with longitudinal axis of hub.At least one localizer is given prominence to from hub, and has the tip engaged with blood vessel wall or the part of localizer.Tip can along the longitudinal axis from hub is spaced apart and from spaced apart second radial distance of longitudinal axis, wherein, the second radial distance can be less than the first radial distance.Localizer can arrange and have at least four parts near hub, and each in described at least four parts can be arranged on axis different accordingly.At least four parts can comprise sweep, and described sweep is arranged in the radius of curvature of Axis Extension along the longitudinal.

Various embodiments another in, provide a kind of be placed on stream transvascular blood stream in filter.Filter comprises hub, at least one anchoring piece and at least one localizer.Hub can axis arranged along the longitudinal.At least one anchoring piece is given prominence to from hub, and comprises hook portion, and described hook portion is penetration rate of blood tube wall when filter is placed in blood vessel, and described hook portion along the longitudinal axis is spaced apart from hub, and first radial distance spaced apart with longitudinal axis.At least one localizer is given prominence to from hub, and has the tip engaged with blood vessel wall or the part of localizer.Tip can axis be spaced apart from hub along the longitudinal, and second radial distance spaced apart with longitudinal axis, wherein, the second radial distance can be less than the first radial distance.Localizer has the Part I away from hub and the Part II near hub.Each in Part I and Part II can be substantial linear, and is arranged on the different axis that tilts relative to longitudinal axis, and wherein, the length of Part I can be greater than the length of Part II.

Various embodiments another in, provide a kind of be placed on stream transvascular blood stream in filter.Filter comprises hub, at least one anchoring piece and at least one localizer.Hub can axis arranged along the longitudinal.At least one anchoring piece is given prominence to from hub, and comprises hook portion, described hook portion penetration rate of blood tube wall, and axis is spaced apart from hub along the longitudinal, and first radial distance spaced apart with longitudinal axis.At least one localizer is given prominence to from hub, and has the tip engaged with blood vessel wall or the part of localizer.Tip can axis be spaced apart from hub along the longitudinal, and second radial distance spaced apart with longitudinal axis, wherein, the second radial distance can be less than the first radial distance.Localizer has the Part I that tilts with longitudinal axis and Part II.Part I can be in the distally of hub, and Part II can be in the nearside of hub, and wherein, the length of Part I is greater than the length of Part II.

Various embodiments another in, provide a kind of and be placed on the filter comprised in the blood vessel of blood vessel wall.Filter comprises hub and first group of component and second group of component.Hub can axis arranged along the longitudinal.Each in first group of component extends from hub.Each in first group of component comprises hook portion, and described hook portion along the longitudinal axis is spaced apart from hub, and each hook portion and longitudinal axis be spaced apart first distance radially.In second group of component each from hub extend and comprise tip, described tip along the longitudinal axis is spaced apart from hub.Each tip can from the longitudinal axis radially spaced apart second distance being less than the first distance.

Various embodiments another in, provide a kind of and place filter in the blood vessel.Filter comprises hub, multiple anchoring piece and multiple localizer.Hub can axis arranged along the longitudinal.Multiple anchoring piece from hub branch out.Each anchoring piece comprises hook portion, described hook portion: (i) penetration rate of blood tube wall, and (ii) can axis be spaced apart from hub along the longitudinal, and (iii) can with longitudinal axis radially spaced apart first distance.Multiple localizer from hub branch out.Each localizer comprises: base segments, and described base segments is near hub; Part I, described Part I extends from base segments along first axle; Part II, described Part II is from Part I along the second Axis Extension, and described second axis can be different from first axle; And tip portion, described tip portion is from Part II along most advanced and sophisticated Axis Extension, and described most advanced and sophisticated axis can be different from first axle and the second axis.Tip portion (i) engages blood vessel wall, and (ii) can axis be spaced apart from hub along the longitudinal, and (iii) can with longitudinal axis radially spaced apart second distance, described second distance can be less than the first radial distance.

Various embodiments another in, provide a kind of and place filter in the blood vessel.Filter comprises hub, multiple anchoring piece and multiple localizer.Hub can axis arranged along the longitudinal.Multiple anchoring piece from hub branch out.Each anchoring piece comprises hook portion, described hook portion: (i) penetration rate of blood tube wall, and (ii) can axis be spaced apart from hub along the longitudinal, and (iii) can with longitudinal axis radially spaced apart first distance.Multiple localizer from hub branch out.Each localizer comprises: base segments, and described base segments is near hub; Tip portion, described tip portion (i) engages blood vessel wall, (ii) can axis be spaced apart from hub along the longitudinal, and (iii) can with longitudinal axis radially spaced apart second distance, described second distance can be less than the first radial distance; And mid portion, described mid portion connects base segments and tip portion.Mid portion can comprise: the first linear segmented, and described first linear segmented extends the first length from base segments along first axle, and described first axle can tilt relative to longitudinal axis; With the second linear segmented, described second linear segmented between tip portion and Part I along the second Axis Extension the second length, described second length can be greater than described first length, and described second axis can tilt relative to longitudinal axis and can be different from first axle.

Various embodiments another in, a kind of filter is provided.Filter will be placed in the blood stream that held by blood vessel wall.Filter comprises: hub, described hub Axis Extension along the longitudinal; With at least one the first component, at least one first component described has the segmentation of the first substantial linear and the segmentation of the second substantial linear.Filter also comprises at least one second component, and at least one second component described has and the third-largestly causes linear segmentation and the fourth-largestly cause linear segmentation.When the first segmentation is around fore-aft axis, the first segmentation limits the part of the first cone.When the second segmentation is around fore-aft axis, the second segmentation limits cylinder.When each in the 3rd segmentation and the 4th segmentation is around fore-aft axis, the 3rd segmentation and the 4th segmentation limit the corresponding part of the 3rd cone and the 4th cone.At least one in 3rd segmentation and the 4th segmentation has the hook portion part of penetration rate of blood tube wall.

Various embodiments another in, provide a kind of blood filter, described blood filter will be placed in the blood stream that held by blood vessel wall.Filter comprises hub, at least one anchoring piece and multiple localizer.Hub can be arranged along the longitudinal axis extended substantially in parallel with blood stream.At least one anchoring piece comprises the hook portion of penetration rate of blood tube wall.At least one anchoring piece limits the generator around the first cone shape of longitudinal axis.First cone shape comprises: (i) is arranged to the summit near hub, (ii) each anchoring piece can axis be spaced apart from hub along the longitudinal, and (iii) each anchoring piece can with longitudinal axis radially spaced apart first distance.From hub branch out and limit the first frustum, described first frustum has the geometric center of axis along the longitudinal to multiple localizer.

In a further aspect, a kind of filter is provided.Described filter can be placed in the blood stream held by blood vessel wall.Filter comprises hub, multiple anchoring piece and multiple localizer.Hub can axis arranged along the longitudinal.Multiple anchoring piece from hub branch out.Each anchoring piece can comprise hook portion, described hook portion: (i) penetration rate of blood tube wall, and (ii) can axis be spaced apart from hub along the longitudinal, and (iii) can from longitudinal axis radially spaced apart first distance.Multiple localizer from hub branch out.Each localizer comprises base segments, and described base segments all arcuately extends from hub.Base segments has the radius of curvature around axis of pitch, and described axis of pitch is in longitudinal axis roughly radially at a distance of second distance place.Each localizer has the tip adjacent with blood vessel wall.The most advanced and sophisticated part near hub can along the longitudinal axis and hub the spaced apart 3rd apart from and four radial distance spaced apart with longitudinal axis, the 4th radial distance is less than the 3rd distance.

Above-mentioned various embodiments can also be included in radiopaque material of on filter hub or as filter hub a part.And above-mentioned various embodiments can also comprise the bioactivator of that be combined with filter or as filter a part.

Various embodiments also provides a kind of blood filter device that makes in Ink vessel transfusing method placed in the middle, and described blood filter device has: multiple localizer, and described multiple localizer extends from hub to limit the first volume; With multiple anchoring piece, described multiple anchoring piece extends from hub to limit the second volume.The method can be realized by following steps, that is: be encapsulated in the first volume by the second volume more than 15%; And the hook portion be arranged on each localizer is joined in blood vessel wall.

Various embodiments also provides a kind of blood filter, described blood filter has hook portion that is dissimilar and that construct and anchoring piece along filter longitudinal axis at different lengthwise position places, to solve the potential problems having insufficient anchoring and tail side (caudal) subsequently or head side (cranial) and move.In an aspect, various embodiments provides blood filter, and described blood filter has and relevant with hook portion to filter anchoring piece penetrates limiter to limit penetrating through blood vessel wall.In an aspect, various embodiments also provides a kind of vascular filter, and described vascular filter is formed by laser cut metal pipe.In one embodiment, the filter be placed in the transvascular blood stream of stream comprises: hub, described hub axis arranged along the longitudinal; Multiple anchorage element, described multiple anchorage element extends from hub, each anchorage element is included in head side extension or the tail side extension at its distal end place, and at least one anchor member distal end along the longitudinal axis each place in first, second, and third distance is spaced apart from hub; With multiple localizer component, each in described multiple localizer component extends from hub between a pair adjacent anchorage element.

Various embodiments also provides a kind of method of the blood filter for the preparation of inserting in body vessel, described method comprises: by filter pleats/be positioned in compact less profile, to be provided for filter hook portion and the resident space of anchoring, and prevent filter hook portion and anchoring piece from interfering the loading of blood filter and/or sending.

In one embodiment, a kind of method of the filter for the preparation of being delivered in body vessel is provided, described filter has six anchorage elements, described six anchorage elements comprise when observing from anchor member distal end around the counterclockwise arranged in succession of periphery of hub first, second, 3rd, 4th, 5th and the 6th anchorage element, described filter also has six localizer components, described six localizer components comprise when observing from anchor member distal end around the counterclockwise arranged in succession of periphery of hub first, second, 3rd, 4th, 5th and the 6th localizer component, described method comprises: anchorage element constrains in the structure of contraction by (i), (ii) one section of first localizer component in the direction of the clock near the first anchorage element is positioned at the rear of the first anchorage element and the second anchorage element, to make the distal end of the first localizer component extend between the second anchorage element and the 3rd anchorage element, (iii) one section of second localizer component is positioned at the rear of the second anchorage element and the 3rd anchorage element, to make the distal end of the second localizer component extend between the 3rd anchorage element and the 4th anchorage element, (iv) one section of the 3rd localizer component is positioned at the rear of the 3rd anchorage element and the 4th anchorage element, to make the distal end of the 3rd localizer component extend between the 4th anchorage element and the 5th anchorage element, v one section of the 4th localizer component is positioned at the rear of the 4th anchorage element and the 5th anchorage element by (), to make the distal end of the 4th localizer component extend between the 5th anchorage element and the 6th anchorage element, (vi) one section of the 5th localizer component is positioned at the rear of the 5th anchorage element and the 6th anchorage element, to make the distal end of the 5th localizer component extend between the 6th anchorage element and the first anchorage element, (vii) one section of the 6th localizer component is positioned at the rear of the 6th anchorage element and the first anchorage element, to make the distal end of the 6th localizer component extend between the first anchorage element and the second anchorage element, (viii) whether inspection is surrounded by the anchorage element with head side extension with the anchorage element of tail side extension, and filter is moved in delivery sheath by (ix).

In one embodiment, a kind of method of the filter for the preparation of being delivered in body vessel is provided, described filter has: N number of anchorage element, described N number of anchorage element distad extends from hub, anchorage element carries out arranging and numbering around the periphery of hub when observing from filter distal end counterclockwise in succession, and each anchorage element is included in head side extension or the tail side extension at its distal end place; With N number of localizer component, described N number of localizer component distad extends from hub, localizer component carries out arranging and numbering around the periphery of hub when observing from filter distal end counterclockwise in succession, each localizer component extends from hub between a pair adjacent anchorage element, each localizer component is arranged so that localizer component n is positioned to clockwise adjacent direct with anchorage element n, wherein N is greater than 5, and described method comprises: anchorage element constrains in the structure of contraction by (i); (ii) one section of localizer component 1 is positioned at the rear of anchorage element 1 and anchorage element 2, to make the distal end of localizer component 1 extend between anchorage element 2 and the 3rd anchorage element 3; (iii) step (ii) is repeated to localizer component 2,3...... and N-2; (iv) one section of localizer component N-1 is positioned at the rear of anchorage element N-1 and anchorage element N, to make the distal end of localizer component N-1 extend between anchorage element N and anchorage element 1; V one section of localizer component N is positioned at the rear of anchorage element N and anchorage element 1 by (), to make the distal end of localizer component N extend between anchorage element 1 and anchorage element 2; (vi) whether inspection is surrounded by the anchorage element with head side extension with the anchorage element of tail side extension; And filter is moved in delivery sheath by (ix).

When combine first brief description accompanying drawing and with reference to following more detailed explanation of the present invention time, these and other embodiment, feature and advantage will become obvious for a person skilled in the art.

Accompanying drawing explanation

Be included in and the accompanying drawing forming the part of this description illustrates the preferred embodiments of the present invention at present herein, and be used from the general description provided above and the following detailed description one provided and explain feature of the present invention.

Fig. 1 is the top-down axonometric chart of the preferred embodiment of blood filter;

Fig. 2 is the bottom-up axonometric chart of the embodiment of Fig. 1;

Fig. 3 is the plane graph of the filter of Fig. 1 on a longitudinal axis a;

Fig. 4 A is the side view of the filter seen along the sight line 4A-4A in Fig. 3;

Fig. 4 B is an arm of the filter of Fig. 1 or the side view of localizer component;

Fig. 5 A is the side view of the filter seen along the sight line 5A-5A in Fig. 3;

Fig. 5 B is the side view of a localizer component of the filter of Fig. 1;

Fig. 5 C is the side view that alternative localizer is arranged, described alternative localizer arranges to have the retaining member be arranged on localizer;

Fig. 5 D is the side view that another localizer is arranged, another localizer described arranges to have supporting member to alleviate or to prevent blood vessel wall from being penetrated by localizer;

Fig. 6 is the close-up side view of the hook portion of the anchorage element of filter for Fig. 1;

Fig. 7 be along with hub outside localizer component rotate around longitudinal axis A or scan, the shape axonometric chart of volume that this localizer component produces;

Fig. 8 be along with hub outside anchorage element rotate around longitudinal axis A or scan, the shape axonometric chart of volume that this anchorage element produces;

Fig. 9 illustrates the volume of the anchorage element can seen outside the volume of localizer component;

Figure 10 to 14 illustrates another preferred embodiment of the hook portion part with withdrawal;

Figure 15 is the axonometric chart of the embodiment of blood filter;

Figure 16 A is the Characteristic Views of the blood filter head side extension in Figure 15;

Figure 16 B and 16C is the view of exemplary head side extension;

Figure 17 A is the close-up illustration of the blood filter tail side extension in Figure 15;

Figure 17 B and 17C is the view of exemplary tail side extension;

Figure 18 is the different axonometric chart of the blood filter in Figure 15;

Figure 19 is another axonometric chart of the blood filter in Figure 15, and it illustrates the parameter of this blood filter;

Figure 20 is the axonometric chart of an embodiment of recoverable component for the blood filter in Figure 15;

Figure 21 A to 21B is the close-up illustration of the alternate embodiments of recoverable component for the blood filter in Figure 15;

Figure 22 is for the preparation of the close-up illustration of a part of this blood filter when loading and send at the blood filter of Figure 15;

Figure 23 is in another close-up illustration of the part of the blood filter of the Figure 15 at preparatory phase place for loading and sending;

Figure 24 is in another close-up illustration of the part of the blood filter of the Figure 15 at preparatory phase place for loading and sending;

Figure 25 is the schematic diagram at another filter seen for the distally end at the preparatory phase place of loading and sending; And

Figure 26 is in another close-up illustration of the part of the blood filter of the Figure 15 at preparatory phase place for loading and sending.

Detailed description of the invention

Explain various embodiments with reference to the accompanying drawings.In any possible place, Reference numeral identical in whole accompanying drawing will be used to indicate identical parts or similar parts.

As used herein, the term for any numerical value or scope " is similar to " or " being similar to " indicates suitable dimensional tolerance, and described suitable dimensional tolerance allows a part for parts or set to play function for the object of planning herein.And as used herein, term " patient ", " host ", " main body " refer to any mankind or animal subject, and will not limit system or the method for mankind's use, although the usage of the present invention in human patients represents preferred embodiment.

Fig. 1 to 14 illustrates preferred embodiment.With reference to Fig. 1, the axonometric chart of filter 100 is shown.Filter 100 comprises hub 10, localizer component 20 and has the anchorage element 30 of hook portion 40.Filter 100 can be made up of many elongated wire rods, and described elongated wire rod is preferably (such as the elgiloy) of metal, and more preferably super-elastic shape memory alloy (such as Nitinol).Wire rod is by suitable interconnection technique (such as welding, laser weld or Plasma Welding) or remain on filter tail end end by being bonded together together by hub 10.Preferably, wire rod is Plasma Welding.As used herein, " wire rod " refers to the slender member of any narrow cross section, it comprises bar, rod, pipe, line and narrow section of cutting away from thin plate, and " wire rod " to be not intended to limit the scope of the present invention to manufactured by the ad hoc approach of metal forming or to get the raw materials ready the cut slender member with circular cross section from wire rod.

Localizer component 20 has nearside localizer end 20P and localizer end, distally 20D.Similarly, anchorage element 30 has nearside anchoring end 30P and anchoring end, distally 30D.As shown in Figure 6, distally anchoring end 30D can be provided with hook portion 40.

With reference to Fig. 4 A and 4B, localizer component 30 can be provided with multiple localizer segmentation, is provided preferably with the segmentation between 3 and 6, and is more preferably provided with four locater segmentation LS1, LS2, LS3 and LS4.First localizer segmentation LS1 can be away from the sweep that hub extends on the first direction of axis A along the longitudinal.In an embodiment, the second localizer segmentation LS2 extends along the second axis 110 substantial linear; 3rd localizer segmentation LS3 extends along the 3rd axis 120 substantial linear; And the 4th localizer segmentation LS4 extends along four axistyle 130 substantial linear.In a preferred embodiment, many axis A, 110,120,130 and 140 parts different from each other are that every bar axis can intersect each other, but do not have one to be basic conllinear each other in these axis.

Localizer segmentation LS2 can distinguish by means of linking part or bending section LJ1 and localizer segmentation LS3.Localizer segmentation LS3 can distinguish via linking part or bending section LJ2 and localizer segmentation LS4.Linking part or bending section LJ1 or LJ2 can be regarded as the crossing position formed by segmentation, thus limit the part of the one-tenth fillet connecting any two segmentations.

Localizer 20 can be from 3 localizers to 12 localizers.Filter embodiment shown in Fig. 4 A comprises six localizers, and described six localizers are roughly angularly spaced apart around axis A.In embodiment in figure 4b, localizer segmentation LS1 extends through the arc with radius of curvature R 1, the fore-and-aft distance L that the center of described radius of curvature R 1 can be positioned at along the axis vertical with longitudinal axis A on radial lateral separation d3 and to measure from the terminal surface 12 of hub 10 along the axis almost parallel with longitudinal axis A ₄on.Localizer segmentation LS2 extends to form first jiao of θ relative to longitudinal axis A along axis 110 ₁, and localizer segmentation LS3 extends to form second jiao of θ along axis 120 ₂.As shown in Figure 4 B, the first localizer linking part or bending section LJ1 can be positioned at the longitudinal length L1 place being roughly parallel to longitudinal axis A with terminal surface 12 apart.As shown in Figure 4 A, the first localizer linking part or bending section LJ1 also can be located at relative to longitudinal axis A substantially vertical axis on longitudinal axis A at a distance of about one half-distance " d ₁" distance, wherein distance d ₁be corresponding radial arrangement localizer 20 to the distance between inner surface.Second localizer linking part LJ2 can be positioned at the longitudinal length L2 place being roughly parallel to longitudinal axis A.Second localizer linking part LJ2 also can be positioned at longitudinal axis A at a distance of about one semidiameter " d ₂" distance.Distance d ₂be the 4th segmentation LS4 of the localizer 20 in corresponding radial arrangement outermost surface between distance.The thickness of localizer component 20 is t ₁.When localizer component 20 is the wire rods with circular cross section, the thickness t of localizer 20 ₁it can be the diameter of wire rod.

Numerical value in certain limit may be used for above-mentioned dimensional parameters, to provide localizer component filter will be placed in vein or blood vessel, filter will be applied as follows in described vein or blood vessel, described mode is: be positioned to by segmentation LS4 with wall of vein or blood vessel wall less parallel and provide the enough side forces being resisted against and wall of vein or blood vessel wall make filter placed in the middle, but described side force is greatly to hurting wall of vein or blood vessel wall.Such as, compared with the filter being intended to be placed in comparatively large vein or blood vessel (such as adult's caval vein or other blood vessel), the filter being intended to be placed in comparatively thin vein or blood vessel (such as human infant caval vein or dog caval vein) can have less size L ₁, L ₂, L ₃, L ₄, LS1, LS2, LS3, LS4, d ₁and d ₂, to make align member can launch fully to realize positioning function and filtering function.In the exemplary embodiment being applicable to adult's vena cava filter, when filter to be at the temperature of main body and to be unfettered time, radius of curvature R 1 from about 0.02 inch to about 0.1 inch, radius R 1 be centrally located at and axis A at a distance of the distance d3 place of about 0.1 inch and the length L of about 0.2 inch ₄place; Distance L ₁it is about 0.3 inch; Distance L ₂it is about 0.9 inch; Distance d ₁(localizer 20 radially arranged to the distance measured between inner surface) is about 0.8 inch; Distance d ₂about 1.5 inches, first jiao of θ ₁about 58 degree, second jiao of θ ₂it is about 22 degree; And the thickness t of localizer ₁it is about 0.013 inch.It should be noted that, the value herein provided is approximation, represent the size within the scope of the appropriate size for the specific embodiment shown in accompanying drawing, and any suitable value can be used, as long as these values allow filter to play the function of plan in the blood vessel of main body.

With reference to Fig. 5 A and 5B, hub 10 can be provided with interior cylindrical opening, and it is distance d that described interior cylindrical opening has ₈the about diameter of twice.Each in multiple anchorage element 30 can be provided with the first anchoring segmentation LA1, a part of described first anchoring segmentation LA1 is arranged in hub 10, described first anchoring segmentation LA1 is connected to the second anchoring segmentation LA2 by the first anchoring linking part or bending section AJ1, and described second anchoring segmentation LA2 can be connected to the 3rd anchoring segmentation LA3 via the second anchoring linking part or bending section AJ2.3rd anchoring segmentation LA3 can be connected to hook portion 40 via the 3rd anchoring linking part or bending section AJ3.First anchoring segmentation LA1 extends obliquely relative to axis A.Second anchoring segmentation LA2 is with the angle θ relative to longitudinal axis A ₃extend obliquely along axis 130 relative to axis A.3rd anchoring segmentation LA3 is with angle θ ₄extend obliquely along axis 140 relative to axis A.Second anchoring linking part or bending section AJ2 can be positioned at the 6th fore-and-aft distance L6 place and the 4th distance d ₄about half place, described 6th fore-and-aft distance L6 is the distance measured from the terminal surface 12 of hub 10 on the axis almost parallel with axis A, described 4th distance d ₄it is the distance measured between the roughly radial end points of two anchoring pieces 30 on the axis that axis A is substantially vertical.3rd anchoring linking part AJ3 can be positioned at the 7th fore-and-aft distance L ₇place and distance d ₇the lateral separation place of about half, described 7th fore-and-aft distance L ₇the distance arrived along the shaft centerline measurement almost parallel with axis A, described distance d ₇it is the distance measured between the inner surface of anchoring piece 30 roughly radial at two on the axis that axis A is vertical.The thickness normally t of anchorage element 30 ₂.When anchorage element 30 is the wire rods with circular cross section, the thickness t of anchoring piece 30 ₂it can be the diameter of wire rod.As shown in Figure 5 B, hook portion 40 can be in fore-and-aft distance L ₁₀the planar abutment at place, described fore-and-aft distance L ₁₀it is the distance of the terminal surface 12 measuring hub 10.The radius of curvature R when feature of hook portion 40 is that at applicable temperature (internal temperature of such as room temperature or main body) is in its expanded configuration ₂.Hook portion radius of curvature R ₂center can be positioned at distance L ₁₁place and distance d ₆half place, described distance L ₁₁the distance measured from the terminal surface 12 of hub 10 along the axis almost parallel with axis A, described distance d ₆it is the distance measured between two roughly radial hook portions 40.The most advanced and sophisticated 40T of corresponding radial hook portion 40 can be positioned at fore-and-aft distance L ₁₂(with the fore-and-aft distance L to the 3rd anchoring linking part AJ3 ₇approximately uniform distance) distance d between place and the hook portion 40 of radial direction ₇half place.

The numerical value of certain limit may be used for above-mentioned dimensional parameters, to provide the anchorage element of filter will be located and be anchored in vein or blood vessel, filter will be applied as follows in described vein or blood vessel, described mode is: hook portion 40 is positioned to wall of vein or vessel wall contact and provides be resisted against enough side forces in wall of vein or blood vessel wall to guarantee that hook portion engages wall of vein or blood vessel wall, but the side force provided is greatly to hurting wall of vein or blood vessel wall.Such as, compared with being intended to be placed on the filter of (such as adult's caval vein or other blood vessel) in larger vein or blood vessel, be intended to the filter be placed in thinner vein or blood vessel (such as child's caval vein or dog caval vein) and less size can be had, to make anchorage element can launch fully to realize positioning function, anchoring function and filtering function.In the exemplary embodiment being applicable to adult's vena cava filter, when filter to be at the temperature of main body and to be unfettered, fore-and-aft distance L ₈it is about 0.02 inch; L ₉it is about 0.2 inch; L ₁₀it is about 1.3 inches; L ₁₁it is about 1.2 inches; d ₆it is about 1.5 inches; d ₇it is about 1.6 inches; d ₈it is about 0.01 inch; d ₉between 1.5 inches and 1.6 inches; L ₁₂it is about 1.2 inches; Radius of curvature R ₂it is about 0.03 inch; And the thickness t of anchorage element ₂it is about 0.013 inch.Most preferably, very little radius of curvature R ₃the feature of anchoring linking part or bending section AJ2, wherein R ₃it can be about 0.01 inch.

Under the situation of extra retentivity can expecting filter, anchorage element can be connected to localizer.A kind of layout is exemplarily shown in figure 5 c, and wherein hook portion 22 can be connected to localizer near tip portion.In this arrangement, tip portion and hook portion 22 are all configured so that localizer passes through to be formed the stopper region 22a and non-penetration rate of blood tube wall that and hook portion 22 most advanced and sophisticated by localizer limit.Another kind of layout can by connecting or being formed and have the hook portion of same configuration for the hook portion 40 of anchorage element and realize.Undesirably utilizing in another layout of hook portion in figure 5d, can arrange one or more stopper element 24 in any suitable position on localizer.As shown in fig. 5d, stopper element 24 is the forms of the truncated cone being connected to localizer.But stopper element 24 can be any structure, as long as component 24 alleviates or prevents localizer penetration rate of blood tube wall.And in another is arranged, hook portion 22 (or hook portion 40) can be combined with stopper element 24, such as, hook portion 22 is connected to the first localizer, hook portion 40 is connected to the second localizer, stopper element 24 is on the 3rd localizer, hook portion 22 and stopper element 24 be combined on the 4th localizer, being combined on the 5th localizer of hook portion 40 and stopper element 24.

With reference to Fig. 6, hook portion 40 can be provided with nearside hook portion part 40P and distally hook portion part 40D, and described distally hook portion part 40D is provided with sharp-pointed most advanced and sophisticated 40T.Hook portion 40 can be formed as having thickness t ₃.When hook portion 40 is the wire rods with circular cross section, thickness t ₃the external diameter of wire rod can be substantially equal to.In an embodiment, hook portion thickness t ₃anchoring piece thickness t ₂about 0.5 to about 0.8.Wire rod can be configured to follow formation radius of curvature R ₂, when filter is at the temperature of main body, described radius of curvature R ₂center be in fore-and-aft distance L ₁₁and radial distance, d ₉place, as mentioned above.Most advanced and sophisticated 40T can be provided with the surperficial 40D of general planar, and the length of described surperficial 40D can be approximately equal to length h ₁.Most advanced and sophisticated 40T can be positioned at the plane distance h tangent with sweep 40S ₂place.

With reference to Fig. 7, localizer 20 is shown, the first compound surface of revolution SR1 that described localizer 20 has been subjected to around axis A limits, and described first compound surface of revolution SR1 is formed around axis A rotation 360 degree by one of them in localizer 20.First compound surface of revolution SR1 comprises a part, the first frustum F1, the second frustum F2 and cylinder C1 of truncated hyperboloid H.With reference to Fig. 8, anchoring piece 30 is depicted as the second compound surface of revolution SR2 be subject to around axis A and limits, and described second compound surface of revolution SR2 is formed around axis A rotation 360 degree by one of them in anchoring piece 30.Limited by anchoring piece 30 second compound surface of revolution SR2 comprises the 3rd frustum F3, the 4th frustum F4 and the 5th frustum F5 respectively.

Some design parameters are considered to allow preferred embodiment to realize exceeding the multiple advantage of existing filter.Multiple advantage such as comprises: filter 100, once resist migration after installing, has larger filter volumetric, and has good proper alignment relative to the inwall of blood vessel.Multiple design parameter can regulate the performance and the mating feature that realize filter, and multiple design parameter such as comprises: the volume V limited by the first surface of revolution SR1 ₁with the volume V limited by the second surface of revolution SR2 ₂ratio, described ratio can be at least 0.92, preferably about 1.0, and be most preferably about 0.99.And, volume V ₂about 15% or more can by volume V ₁surround, preferably volume V ₂about 25% or more can by volume V ₁surround, and most preferably volume V ₂about 35% can by volume V ₁surround, so as to make as in Fig. 9 by volume V ₃shown, volume V ₂not by volume V ₁the part of surrounding is (that is, at the first volume V ₁outside volume V ₂) be about 0.4 cubic inch.And have been found that in a preferred embodiment, along with the cross-sectional area of hook portion increases, when filter 100 is arranged in simulated blood vessel, filter 100 trends towards resisting and moves.Similarly, radius of curvature R is worked as ₂reduce, when keeping other parameter constant, the resistance of resisting movement in simulated blood vessel increases simultaneously.

Material for filter can be any biocompatible material suitably, such as polymer, memory polymer, memory metal, hot memory metal, metal, metal alloy or pottery.Preferably, material can be elgiloy, and most preferably, material can be Nitinol, and Nitinol is hot marmem.

Localizer and anchorage element use the shape-memory material of such as Nitinol, it is convenient to filter (that is, unconstrained) structure from its normal expansion and radially is retracted to the structure of contraction towards its longitudinal axis in insertion body vessel.The performance of Nitinol allows filter member withstand huge distortion (such as, 8 times to stainless distortion) and do not affect the ability that filter returns to reservation shape.This is because crystalline phase changes between the austenite and softer martensite of rigidity.This phenomenon enables implant be loaded onto to have in the delivery sheath of very little diameter, this remarkably reduces to arrive to insert wound caused by position and complication.

(A can be in particular by material is remained on transformetion range _f) more than while, transformation stress level increase up and down or reduce material deformation to realize the transformation of material between morphology of martensite and Austenite Morphology.This is even more important for hook portion, and when this is the challenge owing to being subject to grumeleuse at filter, hook portion can be out of shape significantly (therefore, becoming martensitic form).Permission is presented its shape wanted once discharging load hook portion by hyperelastic character again.

When longitudinal force is applied to hub 10 along the direction (that is, towards the hub 10 of filter) of BF, during filter is removed, hook portion can be regained from postcava (" IVC ") wall.Under this concentrated stress, hook portion will straighten and be converted to martensitic state, become super-elasticity thus.Therefore, hook portion 40 is designed to bend towards substantially straight structure when applying specific hook portion migration force and just bounce back into its original-shape once removal hook portion migration force.

Or, the temperature of shape-memory material can be reduced to A _fto cause the crystalline phase of material to change below temperature, thus material is made to have become ductility at loading or during regaining filter.Multiple technologies can be used to change crystalline phase, the fluid of such as cool brine, low temperature or heat conductor.

By the feature of hot shape-memory material, localizer and anchorage element can be cooled to martensite transfor mation and become below austenitic transition temperature, and then straightening and remaining on shrinks in straight form, the straight form of described contraction can have the thin plastic pipe material of about 2 millimeters of (mm) internal diameters through one section, such as #8 France's conduit (French catheter).Under high temperature form (as being in body of mammals), filter 10 returns to preformed filtration shape as shown in Figure 1.Or localizer and/or anchorage element can be made up of the wire rod of spring metal, and the wire rod of described spring metal can straighten and be compressed in conduit or pipe, and bifurcated is become the filter shape of Fig. 1 when pipe is removed.

At high temperature (such as, about 500 DEG C) can be passed through filter member annealing is set to shape and the structure of the expansion of filter member while the intended shape keeping filter member.Then, no matter when filter is in austenite kenel (that is, becomes austenitic transition temperature or A in martensite transfor mation _fat temperature more than temperature), filter member all turns back to shape memory.Such as, in U.S. Patent No. 4,425, disclose the method for the high temperature form for setting filter in 908, the whole content of described patent is by reference to being contained in this.

Under the high temperature form of shape-memory material, filter has the first and second roughly coaxial filter webs or sieve, and each filter webs is roughly symmetrical around the longitudinal axis of filter, and two filter webs are recessed relative to the front end of filter.

The filter screen V formed by anchorage element 30 ₂be primary filter, and can be reach 12 isolated anchorage elements 30 of circumference.Six anchorage elements 30 shown in embodiment in the accompanying drawings.Anchorage element can have equal length, but can have different length, to make the hook portion 40 of the end being in wire rod will be assemblied in conduit in not interconnective situation.Anchorage element 30 in FIG shown in expanded configuration (namely, free structure under high temperature form) in become small angle with blood vessel wall, described small angle is preferably in the scope of ten degree to 45 degree, and hook portion 40 penetration rate of blood tube wall with anchoring filter in case its motion.Anchorage element 30 radially offsets relative to localizer component 20, and radially can be positioned at the centre between localizer component 20, and can be spaced apart with the arc circumference of 60 degree as shown in Figure 3.Localizer component 20 forms sieve V ₁.Thus, the filter screen V of combination ₁and V ₂can provide the wire rod of radially locating around hub 10, described wire rod such as has the arc of 30 degree at the greatest divergence place of each filter sections.In an illustrated embodiment, with reference to the direction by the blood stream BF shown in the arrow in Fig. 2 and 4A, filter sections V ₂formed towards the frustum of the hub 10 of filter 100, and filter sections V ₁form the recessed sieve of roughly frustum-shaped, the geometric center of described recessed sieve is near the end 12 of hub 10.In a preferred embodiment, the volume V of surperficial SR1 ₁can between about 0.3 cubic inch and about 1.1 cubic inches, preferably about 0.7 cubic inch, and the volume V of surperficial SR2 ₂can between about 0.3 cubic inch and about 1.1 cubic inches, preferably about 0.7 cubic inch.

The structure of hook portion 40 is considered to be important in the following areas: filter is once installation is resisted migration, allowed filter to remove from blood vessel after installation later simultaneously.With regard to the hook portion on the anchorage element with regard to being formed in known permanent vena cava filter, when filter 100 is expanded with by time in place for filter anchoring, these hook portion 40 penetration rate of blood tube walls, and prevent filter at the Ink vessel transfusing vertical migration along either direction.But, when hook portion 40 is implanted and when being covered by endothelial layer subsequently, hook portion 40 and filter can be withdrawn and can not injure significantly or tear caval vein.It is acceptable for recalling caused less injury (destruction of such as Human Umbilical Vein Endothelial Cells layer or local caval vein wall perforation) due to hook portion.

In order to allow to remove filter safely, can relative to the thickness t of anchorage element 30 ₂or the remainder of cross section and hook portion 40 suitably reduces the cross section connecting section 40S.The size of connection section 40S can be set to that making to expand to connect section 40S when allowing hook portion 40 to penetrate caval vein wall when anchorage element 30 has enough rigidity.But when hook portion will be recalled from blood vessel wall, the power of recalling along the direction of blood stream BF will cause connection section 40S flexing, the most advanced and sophisticated 40T of hook portion will be made to move (that is, hook portion straightens) towards the position with axis A parallel.When hook portion so straightens, filter can be recalled and can not tear blood vessel wall, only leaves less perforation simultaneously.In an embodiment, anchorage element 30 has the cross-sectional area of about 0.00013 square inch, and hook portion 40 (especially bending connection section 40S) has the cross-sectional area of about 0.000086 square inch.

With reference to Fig. 6, it should be noted that whole hook portion 40 can be formed with the cross section t running through its length ₃, described cross section t ₃(it has thickness t to be less than localizer component 20 ₁) or anchorage element 30 (it has thickness t ₂) cross section.As a result, axially the power of recalling will trend towards hook portion 40 is straightened over the whole length.This elasticity in hook structure is considered to prevent hook portion from during recalling, tearing blood vessel wall.

As indicated previously, although filter can be made up of ductile metal alloy (such as rustless steel, titanium or elgiloy), be preferably made up of Nitinol.Nitinol is a kind of material of low modulus, and it allows the localizer of device 100 and anchorage element to be designed to have lower contact force and pressure, still obtains enough anchoring strengths simultaneously and moves with resisting apparatus.Make hook portion 40 open required power and can be modulated into total power of resisting required for filter migration.This or can pass through Material selec-tion and realize by cross-sectional area or the geometry of change hook portion, as mentioned above.

Except temperature sensitivity, Nitinol is also subject to stress sensitivity when time under the austenitic state being in high temperature, and crystal transition, the simultaneously temperature of material that described stress sensitivity can cause material to be transformed into martensitic state from austenitic state remain on more than transition temperature.By reducing the cross-sectional area of part or all in hook portion 40 relative to the cross-sectional area of anchorage element 30 or localizer component 20, when longitudinal force along BF direction (namely, hub 10 towards filter) when being applied to hub 10 such as to remove filter, stress will concentrate in the region of the cross section of reduction.Under the stress that this is concentrated, the part of the reduction cross section of hook portion can be transformed into martensitic state, becomes elastic thus, to make the part of the reduction cross section of described hook portion straighten.Thus, no matter be made by Nitinol, elgiloy, spring metal or be made of plastics, hook portion 40 is all designed to bend towards substantially straight structure when applying specific hook portion migration force and just bounce back into its original-shape once removal hook portion migration force.

Make hook portion 40 be out of shape required power or stress can be relevant to following parameter, that is: be applied to the power of each hook portion of device when it blocks completely and allow the blood pressure in blood vessel to reach 50 millimetress of mercury (mmHg) in testing stand.Testing stand (not shown) can be configured with one section of tubing (having multiple internal diameter) and suitably be attached to this tubing to allow filter.This tubing is connected to another tubing, and the ends exposed of another tubing described is in ambient air and mark the amount of the pressure reduction indicated across filter by grade, and the amount of described pressure reduction is relevant to the power of each localizer being applied to filter 100.For there is the pressure reduction of at least 50 mm Hg in the blood vessel of 28mm, this power on each anchoring piece of six anchoring piece devices at least about 70 grams.For the embodiment of the vena cava filter for adult's main body, gross migration resistance for the expectation of filter is considered to about 420 grams, and can add the anchorage element 30 more with hook portion 40 to reduce the maximum migration force for each hook portion.Load on filter will be less accordingly in the blood vessel of small diameter.Preferably, hook portion 40 at about 10mm Hg until perform as anchoring mechanism under predetermined filter migration resistance in the scope of about 150mm Hg to 200mm Hg.If hook portion 40 maintains its geometry within the scope of this under predetermined filter migration resistance, the then higher power that preferably applies in response to the direction (namely along the direction of the filter rear end TE relative to blood stream) along hub of hook portion 40 and start distortion, and discharge under the power of power being substantially less than the breakage of Hui Shi vascular tissue.The ability straightened in a way of hook portion is allowed for preferred embodiment filter is removed from blood vessel wall safely.

At filter 100 after Ink vessel transfusing maintains the time reached more than two weeks in place, hook portion 40 will grow endothelial layer.But, because these hook portions 40 become with blood vessel wall with the substantially straight wire rod section of less angle orientation when being subject to the power of recalling along the direction (that is, towards rear end TE) of hub, therefore, filter can be removed, thus in the surface of endothelium, only leave the damage of six thorn points.In order to realize above-mentioned effect, conduit (such as by reference to being contained in this U.S. Patent No. 6,156, shown in 055 and described unit) or similar withdrawal unit are inserted on hub 10 and engage with localizer component 20.Although hub 10 keeps static, conduit can move downward, thus forces localizer component 20 to fold towards axis A, and engages anchorage element 30 subsequently and force anchorage element 30 downward, recalls hook portion 40 thus from endothelial layer.Then, hub 10 can be pulled back in conduit to make whole filter 100 be contracted in conduit.When filter is formed by shape-memory material, cooling fluid (such as, cool brine) can make filter shrink through conduit with help during these steps.

The main purpose of hook portion 40 guarantees that filter does not move in normal respiratory function process or when there is Massive pulmonary embolism.Normal postcava (IVC) pressure is considered between about 2mm Hg and about 8mm Hg.The IVC of blocking can be pressurized to 35mm Hg potentially under blocking.In order to ensure the stability of filter, therefore can select across the 50mm Hg of filter pressure drop as removable filter 100 filter migration resistance design standard.When the removable pressure being greater than at least 50mm Hg is applied to filter, hook portion 40 will be out of shape and be discharged from blood vessel wall.Make hook portion be out of shape required for pressure can by following calculating converting to force.

Due to 51.76mm Hg=1.0 pound per square inch (psi), so 50mm Hg=0.9668psi.

For the caval vein of 28mm:

A = \frac{π}{4} {(28)}^{2} {mm}^{2} = 615.4 {mm}^{2} = 0.9539

Square inch

Migration force is by following calculating: f=P × A

0.9668psi × 0.9539 square inch=0.9223 pound=418.8 grams

It should be noted that the power required for pressure of resisting at least 50mm Hg also increases along with caval vein diameter increases.According to the quantity of filter hook portion, the intensity of each hook portion can be calculated.For there is the device of six hook portions:

In other words, for filter 100, each hook portion power that must can resist about at least 70 grams is with the barometric gradient of at least 50mm Hg in the blood vessel resisting 28mm.

In order to prevent excessive vascular trauma, each independent hook portion needs to be relatively weak.By the balance quantity of hook portion and the intensity of independent hook portion, the injury of minimum blood vessel can be realized, still maintain the barometric gradient standard of at least 50mm Hg or other the predetermined pressure gradient standard a certain in the scope from 10mm Hg to 150mm Hg simultaneously.

With reference to Fig. 4 A, anchorage element 30 can from anchoring linking part or bending section AJ1 outwards at angle, but the outer end of described anchoring linking part or bending section AJ1 and each anchorage element 30 is adjacent spaced away.When anchorage element 30 is discharged in body vessel from the compressive state conduit or other pipe, this bending section in each anchorage element is guaranteed: in fact hook portion 40 is spring loaded in pipe, and these hook portions 40 are launched to intersect along with from pipe.Because anchorage element 30 is outside at angle from shoulder 30, therefore, hook portion 40 is recalled along with insertion tube and outwards launches fast.

In another embodiment, in blood filter, can bioactivator be included, such as, by the coating in the part of filter, or on filter, in filter or the soluble structure that is attached to filter.Bioactivator can be included in this filter as a part for filter, so that treatment or prevent other patient's condition relevant to filter (such as, infecting or inflammation), or other patient's condition that treatment and filter self have nothing to do.More specifically, bioactivator can include but not limited to: medicament, such as antiproliferative/antimitotic agent, it comprises natural products, such as vinca alkaloids (namely, vincaleucoblastine, vincristine and vinorelbine), paclitaxel, epipodophyllotoxin (epidipodophyllotoxin) (namely, etoposide, teniposide), antibiotic (dactinomycin (actinomycin D) rubidomycin, amycin and darubicin), anthracycline, mitoxantrone, bleomycin A5, mithramycin (mithramycin) and mitomycin, enzyme (L-asparaginase, it systematically makes left-handed asparagine produce metabolic alterations and removes the cell not synthesizing the asparagine ability of himself), anticoagulant, such as G (GP) II b/IIIa inhibitor and vitronectin receptor antagonist, antiproliferative/resisting mitosis alkylating agent, such as nitrogen mustards (mechlorethamine, cyclophosphamide and isoreagent, melphalan, chlorambucil), aziridine and methyl melamine (hexamethylmelamine and tespamin), alkylsulfonate-Busulfan, nitroso ureas (nirtrosoureas) (bcnu (BCNU) and isoreagent, streptozotocin) and triazenes-dacarbazine (triazenes-dacarbazinine), antiproliferative/antimitotic antimetabolite, such as folic acid isoreagent (methotrexate), pyrimidine isoreagent (fluorouracil, floxuridine and cytosine arabinoside), purine isoreagent and related inhibitors (purinethol, thioguanine, pentostatin and 2-chlorine deoxidation gland { cladribine }), platinum complex (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide, hormone (that is, estrogen), anticoagulant (heparin, the heparinate of synthesis and other thrombin inhibitor), fibrinolytic agent (such as, tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, persantin, ticlopidine, clopidogrel, abciximab, migration inhibitor (antimigratory agent), secretion inhibitor agent (such as, brefeldin (breveldin)), antiinflammatory, such as adrenocortical steroid (hydrocortisone, cortisone, fludrocortisone, prednisone, Bo Nisonglong, 6-α-methylprednisolone, omcilon, betamethasone, and dexamethasone), on-steroidal agent (salicyclic acid derivatives, that is, aspirin, P-aminophenol derivatives, that is, acetaminophen, indole and indeneacetic acid (indomethacin, sulindac and etodolac (etodalac)), iso-aryl acetic acid class (Tolmetin, diclofenac and ketorolac), arylprop acids (ibuprofen and derivant), anthranilic acid (mefenamic acid, and meclofenamic acid), enol acid (piroxicam, tenoxicam, Phenylbutazone and oxyphenbutazone), Nabumetone, gold compound (auranofin, aurothioglucose, Kidon (Ono)), immunosuppressant, (ciclosporin, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil), angiogenic agent, such as VEGF (VEGF), fibroblast growth factor (FGF), angiotensin receptor antagonist, nitric oxide donors, antisense oligonucleotide and its combination, cell cycle inhibitor, such as mTOR suppresses body, and the signal transduction kinase inhibitor of growth factor receptors, biostearin (retenoids), cyclin/CDK inhibitor, HMG CoA reductase inhibitor (statins), and protease inhibitor.

Filter delivery unit (not shown) is (such as by reference to being contained in this U.S. Patent No. 6,258, unit described in 026) be suitable for the position roughly placed in the middle that to be delivered to by filter 100 by conduit or delivery tube in body vessel, as illustrated in further detail in above-mentioned patent.Preferably, delivery system can be delivery system shown in United States Patent (USP) 2009/0318951A1 He described, and the full content of this patent is by reference to being contained in this.

In an embodiment, in a part for filter, preferably in the hub 10 of filter, radiopacity material can be included.As used herein, radiopacity material is any such material, namely, described material when being in mammalian body by being gone out by the radiography recognition of devices that machine or the mankind read, described material with example but unrestriced mode such as comprises gold, tungsten, platinum, barium sulfate or tantalum.The use in the filter of radiopacity material allows clinicist to use radiographic apparatus by the Ink vessel transfusing of filter arrangement in main body.Radiopacity material can be the form of the extra structure of adding hub to, such as, around hub assembly or the soldering be in hub assembly or wire rod, lid, sleeve, pad.

Replace, as hub 10 in the above-described embodiments, the withdrawal hook portion of a part for filter for installation 200 can being provided as, shown in embodiment as shown in Figure 10.Filter for installation 200 comprises hub 210, and described hub 210 has regains hook portion 220.Hook portion 220 is configured to be used to regain filter 200 from main body by snaring device (snaring device).With reference to Figure 11 and 12, regain the component 230 that hook portion 220 can be formed as overall together with hub 210, or be formed through the component that suitable technology (such as EDM, laser weld, Plasma Welding, Welding, welding, soldering or bonding) is attached to the separation of hub 210.In a preferred embodiment, component 230 can be the steel billet component of machining, and it has the blind hole 240 formed by a part for hub 210.Hook portion part 220 comprises inclined-plane 250 and 260, and described inclined-plane 250 and 260 is considered to favourable part and is, allows regain filter 200 and can not fetter at catheter opening place due to the skew in-position of filter 200.In other words, can have following situation during removal program, that is: the axis 300 of component 230 is not generally with the longitudinal axis parallel of conduit retraction mechanism or aim at.Can recognize in these cases in order that retentivity is larger, the probability that hook portion is obstructed on duct entry is larger, makes the withdrawal process of filter become complicated thus.Can recognize in order that by inclined-plane 250 and 260, substantially reduce constraint or hinder.Especially, as shown in figures 13 and 14, inclined-plane 250 comprises the radius of curvature R 4 being connected to flat 252 and 254.Flat 254 can be connected to the hook portion part 256 of the surperficial R6 with fillet.As shown in Figure 13, flat 252 is connected to the part R7 that another becomes fillet.To it should be noted that accompanying drawing provided herein is relative to each parts bi-directional scaling shown in each accompanying drawing.

The numerical value of certain limit may be used for above-mentioned dimensional parameters, to provide the withdrawal hook portion 230 that a part for localizer component 20 and anchorage element 30 can be remained in blind hole 240.Such as, less filter can have less size, so that compared with the filter being intended to be placed in comparatively large vein or blood vessel (such as adult's caval vein or other blood vessel), regains hook portion 230 and there is not unsuitable obstruction in vein.In addition, regaining hook portion 230 can be made up of radiopacity material or comprise radiopacity material, to allow clinicist to use radiographic apparatus to be arranged in main body by hook portion, engages retraction mechanism such as to help hook portion.

In embodiment in fig .15, filter 300 is made by laser cut metal pipe, and comprises hub 310, localizer component 320 and anchorage element 330.Localizer component 320 comprises nearside localizer end 320P and localizer end, distally 320D, similar with the localizer component 20 of Fig. 1.Similarly, anchorage element 330 comprises nearside anchoring end 330P and anchoring end, distally 330D.Anchoring end, the distally 330D of each anchorage element 330 comprises extended element.In an illustrated embodiment, four in six anchorage elements comprise a side (cranial) extension 340, and in six anchorage elements all the other two comprise tail side (caudal) extension 350.In other embodiments, extended element can differently distribute.Such as, the quantity with the anchorage element of head side extension 340 can be less than or more than four, and with the quantity of the anchorage element of tail side extension 350 can be one, three or more.Both head side extension 340 and tail side extension 350 are bifurcated into and penetrate component and penetrate limiter.Penetrate member designs and become penetration rate of blood tube wall, and penetrate slicer design become restriction penetrate penetrating of component.

Figure 16 A illustrates the close-up illustration of the head side extension 340 in Figure 15.In the exemplary embodiment being applicable to adult's vena cava filter, when filter is in unfettered at the temperature of main body, radius of curvature R ₂it is about 0.03 inch; Length h ₁it is about 0.02 inch; Length h ₂it is about 0.04 inch; Length h ₃it is about 0.01 inch; Length h ₄it is about 0.07 inch; Angle θ ₅it is about 46 degree; Angle θ ₆it is about 15 degree.It should be noted that the value provided is approximation herein, represent the size in the scope of the appropriate size for the specific embodiment shown in accompanying drawing, and any suitable value can be used, as long as these values allow filter to be used in the blood vessel of main body.Geometry and bending will being convenient to of head side hook portion 342 are removed from blood vessel, although should be noted that described bend to have be less than the substantially straight various number of degrees.Required pressure is out of shape about the above-mentioned side hook portion 342 that makes calculated of use, because the quantity of head side hook portion 342 in filter 300 is four, required hook portion intensity is about 104.7 grams (418.7/4), this means that each hook portion minimumly must can resist the power of about 105 grams, to resist the barometric gradient of at least 50 mm Hg in the blood vessel of 28mm for filter 300.

The view of head side extension exemplary shown in Figure 16 B to 16C.Head side extension 340 ' is bifurcated into a side hook portion 342 ' and head side limiter 344 ' from base portion 346 '.Base portion 346 ' has the width being greater than anchorage element 330 ', described base portion 346 ' extends to provide larger width to both head side hook portion 342 ' and head side limiter 344 ' from described anchorage element 330 ' in an illustrated embodiment, and helps head side limiter 344 ' to limit penetrating of head side hook portion 342 '.In embodiment in fig. 16b, head side hook portion 342 ' has the part of the convergent extended from base portion crotch with both head side limiters 344 ', but the part of this convergent is optional.Head side hook portion 342 ' prevents filter after deployment towards the head lateral movement of heart, and head side hook portion 342 ' is configured with design and the feature of hook portion 40 as shown in Figure 6 and as herein described in one embodiment.Head side hook portion 342 ' can have the thickness reduced relative to anchorage element 330 ', and the thickness of described reduction forms to realize the rigidity expected by local amendment before filter is formed or after being formed.Such as, when side hook portion 342 ' is formed from tubes right overhead, the flexibility of head side hook portion 342 ' can by removing material in the position of hook portion 342 ' from the inner surface of pipe or outer surface and finely tune partly.As above discuss described in hook portion 40, head side hook portion 342 ' can be configured to bend towards substantially straight structure when applying specific hook portion migration force, and just bounces back into its original-shape once removal hook portion migration force.

Figure 16 C illustrates the head side extension 340 ' launched in the blood vessel, and head side hook portion 342 ' penetration rate of blood tube wall 3 and head side limiter 344 ' contact blood vessel wall 3 to prevent a side hook portion 342 ' overpenetration.The structure of head side extension 340 ' (such as, by base widths, limiter length, hook portion flexible etc.) is preventing the penetration range of same limit head side hook portion 342 ' of a lateral movement.Head side limiter 344 ' is formed with nonpenetrating distal end to prevent penetration rate of blood tube wall 3.But in certain embodiments, head side limiter 344 ' can be used as the preventing member of tail lateral movement and/or can be configured for the preventing member of tail lateral movement.In an illustrated embodiment, head side limiter 344 ' is substantially straight relative to anchorage element 330 '; But in other embodiments, head side limiter can be bending or at angle.Head side limiter also can comprise that combination illustrates with lower tail side limiter and illustrates, in mini-tablet form distal end of widening.

Figure 17 A illustrates the close-up illustration of the tail side extension 350 in Figure 15.In the exemplary embodiment being applicable to adult's vena cava filter, when filter is in unfettered at the temperature of main body, radius of curvature R ₄it is about 0.3 inch; Length h ₅it is about 0.05 inch; Length h ₆it is about 0.05 inch; Length h ₇it is about 0.1 inch.It should be noted that the value provided is approximation herein, represent the size in the scope of the appropriate size for the specific embodiment shown in accompanying drawing, and any suitable value can be used, as long as these values allow filter to be used in the blood vessel of main body.

The view of tail side extension exemplary shown in Figure 17 B to 17C.Tail side extension 350 ' is bifurcated into tail anchors 352 ' and tail side limiter 354 ' from base portion 356 '.Base portion 356 ' has the width being greater than anchorage element 330 ', described base portion 356 ' extends to provide larger width to both tail anchors 352 ' and tail side limiter 354 ' from described anchorage element 330 ' in an illustrated embodiment, and helps tail side limiter 354 ' to limit penetrating of tail anchors 352 '.In the embodiment shown in Figure 17 B, both tail anchors 352 ' and tail side limiter 354 ' sentence constant width extension from base portion bifurcated.But in other embodiments, both tail anchors 352 ' and tail side limiter 354 ' can comprise the tapered portion similar with the tapered portion of head side extension 340 '.Tail anchors 352 ' prevents filter after deployment away from the tail lateral movement of heart, and tail anchors 352 ' is configured with distal blade, and described distal blade is configured to penetrate blood vessel.Tail anchors 352 ' can have the thickness reduced relative to anchorage element 330 ', and the thickness of described reduction forms to realize the rigidity expected by local amendment before filter is formed or after being formed.Such as, when tail anchors 352 ' is formed from tubes, the flexibility of tail anchors 352 ' can by removing material in the position of anchoring piece 352 ' from the inner surface of pipe and finely tuning partly.

Figure 17 C illustrates the tail side extension 350 ' launched in body vessel, and tail anchors 352 ' penetration rate of blood tube wall 3 and tail side limiter 354 ' contact blood vessel wall 3 to prevent tail anchors 352 ' overpenetration.The structure (such as, by base widths, limiter length etc.) of tail side extension 350 ' is preventing the penetration range of same limit tail anchors 352 ' of tail lateral movement.Tail side limiter 354 ' is formed with nonpenetrating distal end to prevent penetration rate of blood tube wall 3.In an illustrated embodiment, tail side limiter 354 ' is bending relative to anchorage element 330 '; But in other embodiments, tail side limiter can be straight or at angle.Tail side limiter can have the length being greater than tail anchors, as shown in Figure 17 B.Or tail side limiter can have the length being equal to or less than tail anchors.Tail side limiter can also comprise best distal end of widening that illustrate with reference to Figure 18,358 forms in small pieces.

In one embodiment, except head side extension and tail side extension or replace head side extension and tail side extension, anchorage element comprises such extension, that is, described extension has the base portion being branched into a side hook portion and tail anchors.

Referring again to Figure 15, filter 300 comprises six localizer components 320 and six anchorage elements 330, and described six localizer components 320 and six anchorage elements 330 to extend and longitudinal axis along filter 300 is arranged from hub 310.Localizer component 320 is alternately plugged between anchorage element 330, to make each localizer component 320 extend from hub between a pair adjacent anchorage element, and vice versa.But in other embodiments, localizer component 320 and/or anchorage element 330 can when not interfering anchorage element 330 and/or localizer component 320 directly adjacent to each other.Each in localizer component 320 has substantially identical size and structure, and comprises four segmentations LS1, LS2, LS3 and LS4, as illustrated in further detail with reference to Figure 19.Although localizer component in the embodiment shown does not comprise hook portion or anchoring piece, one or more localizer component can comprise extension as described herein, hook portion and/or anchoring piece in other embodiments.In other embodiments, total anchorage element and localizer component can more than or be less than 12 shown in illustrated embodiment.

In fig .15, the length that six anchorage element 330 longitudinal axis had from hub 310 along filter, three kinds of measuring are different, from the first length/distance (that is, L in Figure 19 that hub 310 measures _10A) the shortest, from the second length/distance (that is, L in Figure 19 that hub 310 measures _10B) be greater than the first length/distance, and from the 3rd length/distance (that is, the L in Figure 19 that hub 310 measures _10C) be greater than the first length/distance and be greater than the second length/distance.In other embodiments, anchorage element can have two kinds of different length or four kinds or more and plants different length.A side extension is comprised at anchorage element, tail side extension, head side hook portion, tail anchors, or the hook portion of other form or anchoring piece are in the embodiment of interior anchorage element, there is provided different anchorage elements to be convenient to filter with staggered pattern to be retracted to filter and to be tied or in the structure sent, and also potentially reducing the necessary parts of delivery system (such as, because hook portion and anchoring piece are according to the such as following compact way alternation sum location illustrated about method for folding, so filter can be sent when not using device hook portion kept or cover in delivery sheath).Anchorage element 330 has substantially straight structure in the distal side of nearside anchoring end 330P, is bent outwardly in the structure that described nearside anchoring end 330P expands at filter from filter longitudinal axis.In other structure, anchorage element 330 can have the one or more segmentations along different Axis Extensions, with above similar with reference to the anchorage element 30 described in Fig. 5 A and 5B.

In six anchorage elements 330, two anchorage elements extend the first distance from hub 310, and two anchorage elements extend second distance from hub 310, and two anchorage elements extend the 3rd distance from hub 310.Each head side extension being included in its distal end place in the anchorage element of a pair first length and the anchorage element of a pair second length.In one embodiment, in (free) structure of filter expansion, the difference between the first length and the second length is measured at the tip of from the beginning side hook portion 342, that is, L as shown in Figure 18 ₁₄.In embodiment in figure 18, L ₁₄it is about 0.05 inch.Each tail side extension being included in its distal end place in the anchorage element of a pair the 3rd length.With head side extension anchorage element and prevent tail lateral movement and the head lateral movement of blood filter with the combination of the anchorage element of tail side extension, make in the expanded position of filter in body vessel stable thus.

In the embodiment shown in Figure 15, the anchorage element of the anchorage element of a pair first length, the anchorage element of a pair second length and a pair the 3rd length is located (that is, 180 degree) relative to one another around hub.From the top view of the filter expanded configuration (such as, see Fig. 3) known, analogize according to clock, a pair anchorage element is located as follows: when the anchorage element of the first length is positioned at and 6 places at 12, the anchorage element of a pair second length is positioned at and 10 places at 4, and the anchorage element of a pair the 3rd length is positioned at and 8 places at 2.Below will explain, so specifically correspondingly positioning and anchoring component, be convenient to prepare filter for loading with send.Or can expect to have other probability relevant to the anchorage element of locating relative to hub, and therefore, will should be understood that, illustrated embodiment is unrestricted.

As shown in Figure 19, localizer component 320 is similar with localizer component 20 in many aspects, comprises multiple localizer segmentation LS1 to LS4.But localizer component 320 has following dimensional parameters, described dimensional parameters can be slightly different from the dimensional parameters of above-mentioned localizer component 20.In the embodiment being applicable to adult's vena cava filter, when filter to be at the temperature of main body and to be unfettered, radius of curvature R ₈it is about 0.35 inch; Length L ₁it is about 0.45 inch; Length L ₂it is about 1.0 inches; Distance d ₁it is about 0.9 inch; Distance d ₂about 1.27 inches, first jiao of θ ₁about 57 degree, second jiao of θ ₂it is about 17 degree; And along segmentation LS ₂the thickness t of localizer 320 ₁about 0.0125 inch, and along segmentation LS ₃the thickness t of localizer 320 ₁also it is about 0.0125 inch.Fore-and-aft distance L _10Aabout 1.45 inches, L _10Babout 1.50 inches, L _10Cabout 1.70 inches, and L ₁₃it is about 2.0 inches; d ₇it is about 1.6 inches; Radius of curvature R ₂it is about 0.03 inch; The thickness t of anchorage element ₂it is about 0.0125 inch.It should be noted that, the value herein provided is approximation, represent and be in for the size in the scope of the appropriate size of the specific embodiment shown in accompanying drawing, and any suitable value can be used, as long as these values allow filter to play the function wanted in the blood vessel of main body.

Should also be noted that, although in the exemplary embodiment the thickness of localizer component 320 and anchorage element 330 be illustrated as run through its length be uniform (such as, there is the thickness identical with the remainder of filter 300), but other embodiment comprises the thickness of the length variations along localizer component.Such as, localizer component and/or anchorage element can comprise the segmentation with different-thickness, or have the thickness along selected segmentation change.Should also be noted that the width of localizer component and/or anchorage element can similarly along its length variations.Such as, in one embodiment, localizer segmentation LS ₁width be greater than the width of other localizer segmentation with clean width.In addition, although the anchorage element 330 of filter 300 is wider than localizer component 320, in other embodiments, localizer component and anchorage element can have identical width, or localizer component can wider than anchorage element.

As described herein, filter 300 is cut by metal (Nitinol) pipe and is formed.Be formed from tubes the thickness that filter 300 can reduce the segmentation (such as head side hook portion 342 and/or tail anchors 352) of filter partly.In laser cut tube and after forming filter, electrobrightening, chemical etching or other similar technique can be used to strengthen surface smoothness for raising corrosion resistance and fatigue life.Should also be noted that filter 300 can be formed by wire rod or sheet material.

Filter hub 310 can comprise withdrawal component 312 as shown in Figure 15.Regain component 312 can be formed by the solid hopkinson bar with extension 313, described extension 313 can insert in the open end of hub 310 as shown in Figure 20, and then soldered, be curled or be for good and all attached to hub 310 in addition.Or, regain component 312 and directly can be formed by the pipe forming filter, as shown in Figure 21 A and 21B.Figure 21 A is the side view regaining component 312, and Figure 21 B is the front view regaining component 312.As can see Figure 21, any amount of pattern and configuration can be cut to strengthen the collectability of filter 300 from pipe.

Figure 22 to 26 illustrates the illustrative methods for the preparation of the filter 300 loaded and send.Anchorage element 330 is relative to each other convenient to filter 300 to be retracted in less profile with the location of other filter component, this part is the interleaved length due to anchorage element 330.Filter 300 comprises six anchorage elements and six localizer components, only for reference, described six anchorage elements and described six localizer components are one after the other numbered the first, second, third, fourth, the 5th and the 6th anchorage element and the first, second, third, fourth, the 5th and the 6th localizer component when observing from anchor member distal end counterclockwise around the circumference of hub 310, wherein, first localizer component is positioned in the direction of the clock near the first anchorage element (that is, extending between the first anchorage element and the 6th anchorage element).To should be appreciated that shown and described method is only an example, and many flexible programs can be had.Such as, although the 3rd segmentation LS of localizer component ₃be described to the rear being positioned at anchorage element, but the equivalent elements in the localizer component of any length or blood filter so can be located.In addition, tab order can change, as localizer component can relative to each other be located.Still additionally, one section of localizer component can be positioned at the rear of the rear of an anchorage element, the rear of three anchorage elements or more anchorage element, instead of one section of localizer component is positioned at the rear of two anchorage elements.

Figure 22 illustrates filter 300, and anchorage element is constrained in the structure of contraction by pipe 4; But, also can there be other constrained procedure and/or device.Pipe 4 slides, until the distal end of pipe adjoins the head side hook portion on the anchorage element of the first length towards anchor member distal end 330D above hub 310.Localizer component 320 is removed (if pipe is initial cover its end) from pipe, to make localizer component 320 be in the structure of its expansion, as shown in Figure 22.As shown in Figure 23, the first localizer component 320 ₁the 3rd localizer segmentation LS ₃be positioned at the first anchorage element 330 ₁with the second anchorage element 330 ₂rear (that is, towards filter longitudinal axis), to make the first localizer component 320 ₁distal end at the second anchorage element 330 ₂with the 3rd anchorage element 330 ₃between extend.As shown in Figure 24, the second localizer component 320 ₂the 3rd localizer segmentation LS ₃then the second anchorage element 330 is positioned at ₂with the 3rd anchorage element 330 ₃rear, to make the second localizer component 320 ₂distal end at the 3rd anchorage element 330 ₃with the 4th anchorage element 330 ₄between extend.

3rd localizer component 320 ₃the 3rd localizer segmentation LS ₃then the 3rd anchorage element 330 is positioned at ₃with the 4th anchorage element 330 ₄rear, to make the 3rd localizer component 320 ₃distal end at the 4th anchorage element 330 ₄with the 5th anchorage element 330 ₅between extend.4th localizer component 320 ₄the 3rd localizer segmentation LS ₃then the 4th anchorage element 330 is positioned at ₄with the 5th anchorage element 330 ₅rear, to make the 4th localizer component 320 ₄distal end at the 5th anchorage element 330 ₅with the 6th anchorage element 330 ₆between extend.5th localizer component 320 ₅the 3rd localizer segmentation LS ₃then the 5th anchorage element 330 is positioned at ₅with the 6th anchorage element 330 ₆rear, to make the 5th localizer component 320 ₅distal end at the 6th anchorage element 330 ₆with the first anchorage element 330 ₁between extend.Finally, the 6th localizer component 320 ₆the 3rd localizer segmentation LS ₃then the 6th anchorage element 330 is positioned at ₆with the first anchorage element 330 ₁rear, to make the 6th localizer component 320 ₆distal end at the first anchorage element 330 ₁with the second anchorage element 330 ₂between extend.

In this particular embodiment, localizer component is except being positioned at the rear of two anchorage elements, when localizer component is also located to observe from the distal end of anchorage element 330D, (namely each localizer component is in the below of the localizer component of previous numbering, thereunder intersect) (that is, the second localizer component is positioned at the below of the first localizer component).Such locating structure is shown in Figure 25, and Figure 25 is simplified to schematically show relative localizer component location (such as, the representative length of the localizer component being positioned at anchorage element rear is only shown).In other embodiments, some in localizer component can instead be positioned on adjacent localizer component.

Once localizer component 320 is in place by threading (threaded), filter is just partially pulled in delivery sheath or classification (staging) sheath 5, as shown in Figure 26.The location of inspection anchorage element extension is to guarantee that the anchorage element with tail side extension is surrounded by the anchorage element with head side extension.In one embodiment, tail side extension is located so that tail side limiter is adjacent one another are, to make smooth surface avoid together catching tail anchors when filter launches.Then check that the location of anchorage element is to guarantee a side hook portion all towards a direction (such as, clockwise).In order to positioning head side hook portion, if such as head side hook portion longitudinal axis or towards different directions dorsad, then along with filter is pulled in delivery sheath, filter distortion.Head side hook portion will be followed the path of minimum drag and will continue distortion, until head side hook portion circumferentially orientation.In one embodiment, head side extension is oriented so that a side hook portion is resisted against on jacket inner wall, and head side limiter is arranged for the available volume that advantageously distributes away from jacket inner wall.Filter, once suitably directed, is eventually pulled completely in delivery sheath.

In one embodiment, the method for the preparation of the filter sent illustrates with reference to the anchorage element of the N number of total quantity extended from filter hub and the localizer component of N number of equal number generally, and localizer component is plugged between anchorage element.As above example, anchorage element and localizer component around the counterclockwise arranged in succession of periphery of hub and numbering, make given localizer component n be positioned to and the given direct clockwise adjacent of anchorage element n when observing from filter distal end.And as above example, anchorage element is included in head side extension or the tail side extension at its distal end place.Assuming that N is greater than 5, after constraint anchorage element, described method comprises: anchorage element constrains in the structure of contraction by (i); (ii) one section of localizer component 1 is positioned at the rear of anchorage element 1 and anchorage element 2, to make the distal end of localizer component 1 extend between anchorage element 2 and anchorage element 3; (iii) step (ii) is repeated to localizer component 2,3...... and N-2; (iv) one section of localizer component N-1 is positioned at the rear of anchorage element N-1 and anchorage element N, to make the distal end of localizer component N-1 extend between anchorage element N and anchorage element 1; V one section of localizer component N is positioned at the rear of anchorage element N and anchorage element 1 by (), to make the distal end of localizer component N extend between anchorage element 1 and anchorage element 2; (vi) whether inspection is surrounded by the anchorage element with head side extension with the anchorage element of tail side extension; And filter is moved in delivery sheath by (ix).

Describe the present invention and described concrete example of the present invention.Although according to specific flexible program with shown illustrate the present invention, person of skill in the art will appreciate that and the invention is not restricted to described accompanying drawing and flexible program.In addition, when above-mentioned method and step instruction with a certain order event, person of skill in the art will appreciate that the order of some step can be modified and these modifications according to flexible program of the present invention.In addition, in possible, some step side by side can perform with parallel process, and sequentially performs as mentioned above.Therefore, when there is flexible program of the present invention (its equivalent of the present invention found in spirit of the present disclosure or in claims), this patent also will be intended to cover these deformation programs.Finally, the full content of all open and patent application of quoting in this description by reference to being contained in this, just look like this particularly and set forth independently each separately disclose or patent application the same.

Claims

1. be placed on the filter in the transvascular blood stream of stream, described filter comprises:

Hub, described hub axis arranged along the longitudinal;

Multiple anchorage element, described multiple anchorage element extends from described hub, each anchorage element is included in head side extension or the tail side extension at its distal end place, one or more in described multiple anchorage element comprise a side extension, remainder in described multiple anchorage element comprises tail side extension, and the distal end of described multiple anchorage element is spaced apart at the different first distance, second distance and the 3rd distance and described hub along described longitudinal axis; With

Multiple localizer component, each localizer component extends from described hub between a pair adjacent anchorage element;

Wherein, described tail side extension comprises the bifurcated of tail anchors and the tail side limiter had from the liftoff extension of tail pendant side group moiety, and the width of described tail side base portion is greater than the width of described anchorage element;

Wherein, described head side extension comprises the bifurcated of head side hook portion and the head side limiter with the liftoff extension of from the beginning pendant side group moiety.

2. filter according to claim 1, wherein, described multiple anchorage element comprises six anchorage elements, and described multiple localizer component comprises six localizer components, wherein, described six localizer components have substantially identical length, each localizer component comprises four segmentations, each in described segmentation is arranged on axis different accordingly, and wherein, four in described six anchorage elements comprise a side extension, and in described six anchorage elements all the other two comprise tail side extension.

3. filter according to claim 2, wherein, at least one anchorage element with head side extension has the distal end of spaced apart described first distance with described hub, and has the distal end of the spaced apart described second distance with described hub with at least one anchorage element of head side extension.

4. filter according to claim 3, wherein, two anchorage elements with head side extension have the distal end of spaced apart described first distance with described hub, two anchorage elements with head side extension have the distal end of the spaced apart described second distance with described hub, and have the distal end of spaced apart described 3rd distance with described hub with two anchorage elements of tail side extension.

5. filter according to claim 4, wherein, described two anchorage elements with tail side extension extend from the opposite side of described hub.

6. filter according to claim 5, wherein, described two anchorage elements with head side extension with the distal end of spaced apart described first distance with described hub extend from the opposite side of described hub, and wherein, described two anchorage elements with head side extension with the distal end of the spaced apart described second distance with described hub extend from the opposite side of described hub, wherein, the width of described head side base portion is greater than the width of described anchorage element, wherein, described head side hook portion comprises the structure of curved configuration in the operating condition and the substantial linear under constraints.

7. filter according to claim 1, wherein, described tail side limiter is included in the sheet element at its distal end place.

8. filter according to claim 1, wherein, described filter is formed by the pipe of Nitinol, and wherein, described filter comprises recoverable component, and described recoverable component is made up individually of metallic rod and is attached to described hub.

9. prepare the method for filter according to claim 4 for one kind, described filter is for delivery in body vessel, described six anchorage elements comprise the first anchorage element when observing from described anchor member distal end around the counterclockwise arranged in succession of periphery of described hub, second anchorage element, 3rd anchorage element, 4th anchorage element, 5th anchorage element and the 6th anchorage element, described six localizer components comprise the first localizer component when observing from described anchor member distal end around the counterclockwise arranged in succession of periphery of described hub, second localizer component, 3rd localizer component, 4th localizer component, 5th localizer component and the 6th localizer component, wherein, described 3rd distance is greater than second distance described in described first Distance geometry, described method comprises:

Described anchorage element constrains in the structure of contraction by (I);

One section of described first localizer component in the direction of the clock near described first anchorage element is positioned at the rear of described first anchorage element and described second anchorage element by (II), to make the distal end of described first localizer component extend between described second anchorage element and described 3rd anchorage element;

One section of described second localizer component is positioned at the rear of described second anchorage element and described 3rd anchorage element by (III), to make the distal end of described second localizer component extend between described 3rd anchorage element and described 4th anchorage element;

One section of described 3rd localizer component is positioned at the rear of described 3rd anchorage element and described 4th anchorage element by (IV), to make the distal end of described 3rd localizer component extend between described 4th anchorage element and described 5th anchorage element;

One section of described 4th localizer component is positioned at the rear of described 4th anchorage element and described 5th anchorage element by (V), to make the distal end of described 4th localizer component extend between described 5th anchorage element and described 6th anchorage element;

One section of described 5th localizer component is positioned at the rear of described 5th anchorage element and described 6th anchorage element by (VI), to make the distal end of described 5th localizer component extend between described 6th anchorage element and described first anchorage element;

One section of described 6th localizer component is positioned at the rear of described 6th anchorage element and described first anchorage element by (VII), to make the distal end of described 6th localizer component extend between described first anchorage element and described second anchorage element;

Whether the described anchorage element with tail side extension of (VIII) inspection is surrounded by the described anchorage element with head side extension; And

Described filter is drawn in delivery sheath by (IV).

10. method according to claim 9, wherein, whether described head side extension is each comprises a side hook portion, and described method is further comprising the steps of: check described head side hook portion towards same direction, otherwise pulls filter described in step (IV) period distortion described.

11. methods according to claim 9, wherein, described constraint step (I) comprises makes pipe slide towards the distal end of described anchorage element on described hub, and described pipe has the length being less than described first distance.

12. methods according to claim 9, wherein, each in described localizer component comprises four segmentations be arranged on corresponding different axis, described four segmentations are numbered from the proximal end of described localizer component continuously to the distal end of described localizer component, and described positioning step comprises the 3rd split fix of described localizer component at the rear of described anchorage element.

13. methods according to claim 9, wherein, after described positioning step (VII), each in described localizer component has and is positioned in the direction of the clock near the part below its localizer component.

14. 1 kinds of methods for the preparation of the filter be delivered in body vessel, described filter has: N number of anchorage element, described N number of anchorage element distad extends from hub, described anchorage element carries out arranging and numbering around the periphery of described hub when observing from filter distal end counterclockwise in succession, and each anchorage element is included in head side extension or the tail side extension at its distal end place; With N number of localizer component, described N number of localizer component distad extends from described hub, the periphery of described localizer component when observing from described filter distal end around described hub carries out arranging and numbering counterclockwise in succession, each localizer component extends from described hub between a pair adjacent anchorage element, each localizer component is arranged so that localizer component n is positioned to clockwise adjacent direct with anchorage element n, wherein N is greater than 5, and described method comprises:

Described anchorage element constrains in the structure of contraction by (I);

One section of localizer component 1 is positioned at the rear of anchorage element 1 and anchorage element 2 by (II), to make the distal end of localizer component 1 extend between anchorage element 2 and anchorage element 3;

(III) is to localizer component 2,3 ... and N-2 repeats step (II);

One section of localizer component N-1 is positioned at the rear of anchorage element N-1 and anchorage element N by (IV), to make the distal end of localizer component N-1 extend between anchorage element N and anchorage element 1;

One section of localizer component N is positioned at the rear of anchorage element N and anchorage element 1 by (V), to make the distal end of localizer component N extend between anchorage element 1 and anchorage element 2;

Whether (VI) inspection is surrounded by the anchorage element with head side extension with the anchorage element of tail side extension; And

(vii) described hub is moved in delivery sheath.